Does the part-145 quality system need to be subject to monitoring?
Yes, the quality system is part of the activities of the part-145 organisation and therefore it should be monitored.
Point 145.A.65 (c) requires that the quality system monitors that the activities are being performed in accordance with the approved procedures. The quality system procedures are included within these approved procedures. This implies that quality system must be subject to audits and the part-145 organisation audit programme/plan needs to reflect this.
Besides that the audits of the quality system shall satisfy the requirement of independent audits. This is further explained in AMC 145.A.65(c)(1) point 11: the independence of the audits should be established by always ensuring that audits are carried out by personnel not responsible for the functions, procedures or products being checked. So, the quality manager cannot audit the quality system in terms of independence of the audit.
Therefore, to audit the quality system, it is acceptable to:
- use competent personnel from a different section/department in the same organisation not responsible for the quality function/procedure, or,
- contract the independent audit element of the quality system to another organisation or a qualified competent person.
The way the quality system is going to be audited has to be described in the MOE and approved by the competent authority.